There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
Reason for recall: There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used. Distribution: Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland, Portugal, Puerto Rico, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and United Kingdom. Quantity: 1493 devices Lot/code info: UDI-DI: 00763000371463; Serial Numbers: NPL1000037 NPL1000042 NPL1000053 NPL1000055 NPL1000056 NPL1000062 NPL1000067 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000076 NPL1000098 NPL1000135 NPL1000137 NPL1000138 NPL1000151 NPL1000160 NPL1000161 NPL1000165 NPL1000173 NPL1000174 NPL1000175 NPL1000179 NPL1000180 NPL1000185 NPL1000186 NPL1000188 NPL1000189 NPL1000191 NPL1000195 NPL1000230 NPL1000238 NPL1000242 NPL1000244 NPL1000245 NPL1000246 NPL1000248 NPL1000249 NPL1000252 NPL1000281 NPL1000292 NPL1000295 NPL1000297 NPL1000301 NPL1000303 NPL1000304 NPL1000305 NPL1000323 NPL1000325 NPL1000331 NPL1000344 NPL1000361 NPL1000363 NPL1000364 NPL1000365 NPL1000370 NPL1000429 NPL1000435 NPL1000443 NPL1000446 NPL1000447 NPL1000453 NPL1000486 NPL1000502 NPL1000504 NPL1000505 NPL1000506 NPL1000507 NPL1000509 NPL1000510 NPL1000514 NPL1000516 NPL1000518 NPL1000519 NPL1000528 NPL1000533 NPL1000555 NPL1000558 NPL1000561 NPL1000562 NPL1000575 NPL1000584 NPL1000585 NPL1000592 NPL1000603 NPL1000606 NPL1000612 NPL1000631 NPL1000634 NPL1000638 NPL1000639 NPL1000652 NPL1000653 NPL1000657 NPL1000776 NPL1000794 NPL1000814 NPL1000815 NPL1000817 NPL1000819 NPL1000834 NPL1000835 NPL1001212 NPL1001236 NPL1001241 NPL1001245 NPL1001246 NPL1001265 NPL1001273 NPL1001282 NPL1001301 NPL1001332 NPL1001339 NPL1001353 NPL1001354 NPL1001364 NPL1001369 NPL1001371 NPL1001389 NPL1001429 NPL1001434 NPL1001435 NPL1001436 NPL1001449 NPL1001464 NPL1001506 NPL1001507 NPL1001512 NPL1001520 NPL1001542 NPL10015
00763000371463
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.